Australia and Vaccines: The Battle for Informed Consent Continues

Informed Consent

[SaneVax: The citizens of Australia are in the midst of a battle to retain their right to fully informed consent or rejection of vaccines. As in many other countries, their national health authorities choose to bury their head in the sand when it comes to adverse reactions instead of investigating adverse events.]

Virus in the System

By Natasha Bita

KIRSTEN and Mick Button were looking forward to a family holiday in Bali when the letter landed in their mailbox.

Vaccine Science?

From the West Australian Health Department, it urged them to vaccinate their children against the flu. A killer new strain of influenza, a mutant mix of human, avian and swine influenza viruses, had swept the country the previous winter, and WA was taking no chances. It offered the flu vaccine free to all children, the only state or territory to do so. “It encouraged us to protect our children,” Kirsten says of the letter. “Our four-year-old, Cooper, has asthma so we thought it was the best thing to do. When you get that letter, you are in a situation where if you don’t vaccinate, you feel like you’re not doing the right thing.”

Kirsten took Cooper and his 11-month-old sister, Saba, to their local GP for the flu shot at lunchtime on April 19 last year. On the way home in the car, Saba would not stop screaming. Back in their beachside home in the Perth suburb of Watermans Bay, Kirsten gave her little girl some Panadol to soothe her, and “she was fine all afternoon”.

After dinner, Kirsten went out for a pilates class, leaving Mick to give Saba a bottle and put her to bed at 7pm. An hour later, he heard moaning over the baby monitor. When he checked on Saba in her upstairs cot she was, Kirsten relates, “burning hot, limp like a rag doll”. Mick called his wife to let her hear their daughter’s whimpers over the phone. “I’d never heard anything like it,” Kirsten says. “I was hysterical. I couldn’t drive; my dad had to drive me back home.” While her fretful parents waited for an ambulance, Saba’s temperature was 40.2 degrees, a high fever.

“She was lying very still and groaning and moaning,” Kirsten says. “She was so white.” In the wailing ambulance, as diarrhoea seeped from Saba’s nappy, her parents panicked as they listened to the machine monitoring their baby’s heart, racing at 238 beats per minute – double the usual rate. When the ambulance arrived at Perth’s Princess Margaret Hospital, doctors and nurses were waiting out the front. Kirsten remembers hearing one of them remark, “It’s another Fluvax baby.”

Flu pandemic
When swine flu emerged from Mexico in April 2009, initial reports were that it was killing one in every 20 people infected. Within eight weeks the virus had swept across four continents, Australia included, prompting the World Health Organisation to declare the first global flu pandemic of the century. In July 2009, federal health minister Nicola Roxon warned that in a “worst-case scenario” 6000 Australians could die from the new flu that had already infected 10,000 people, killed 22 and landed 60 others in intensive care. It was highly contagious and it was striking in unpredictable ways: fit, healthy young people normally strong enough to fight off the seasonal flu were being taken down. At its worst it was causing organ failure and brain damage and fears were held for pregnant women, the elderly and people with underlying medical conditions.

The race was on for a vaccine and CSL – the now-privatised Commonwealth Serum Laboratories, Australia’s biggest pharmaceutical manufacturer – was awarded a $131 million government contract to supply the nation’s entire stockpile of swine flu vaccine. CSL began clinical trials of Panvax, which protected against swine flu but not the typical strains of seasonal flu, in 470 children in August 2009. It was approved for children in December by the Therapeutic Goods Administration – the Health Department agency that approves and monitors pharmaceutical products – and administered without any unforeseen side-effects.

Three months later, CSL rolled out a new vaccine, Fluvax, which many GPs promoted to parents as being superior to Panvax because it would protect against seasonal flu as well as swine flu. As the only Australian-made flu vaccine, Fluvax had been on the market for 42 years covering three strains of the most common flu viruses circulating each winter. But something about the 2010 “recipe” was different. In a world-first, CSL’s Fluvax mixed H1N1 swine flu with two strains of seasonal flu. Unlike Panvax, this new trivalent version of Fluvax had not been clinically tested in children before the TGA gave doctors the green light for mass vaccinations of healthy babies, toddlers and pre-schoolers.

What followed has shaken public confidence in one of the world’s most popular immunisation programs.